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Trial Title:
Comparative Study Between Shear and Strain Elastography in Monitoring the Response to NAC in Breast Cancer Patients
NCT ID:
NCT05852743
Condition:
Monitoring the Response of Breast Cancer to Neoadjuvant Chemotherapy Using SE and SWE
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
shear wave and strain elastography
Description:
shear wave elastography is a quantitative technique , while strain elastography is
qualitative technique
Summary:
The aim is to evaluate tumor stiffness changes through a comparative study between shear
and strain elastography in monitoring the response of breast cancer to neoadjuvant
chemotherapy
Detailed description:
Breast cancer (BC) is one of the most common malignant tumors in global population, with
the highest morbidity and mortality rates among female.(1) Neoadjuvant chemotherapy (NAC)
has become an important supplement of comprehensive and precise treatment of BC.
Neoadjuvant chemotherapy (NAC) is increasingly used to induce tumor shrinkage, thereby
allowing smaller surgical resection, eliminating clinically silent micro metastases, and
providing prognostic information based on the extent of pathologic response(.2-4)
Pathological complete response (pCR) is increasingly seen after neoadjuvant chemotherapy
(NACT) for invasive breast cancer. Confident identification of pCR may lead to less
radical breast surgery and to sentinel node biopsy rather than axillary clearance in
women with pre-treatment positive nodes.(5)Response to NACT is routinely assessed using
magnetic resonance imaging (MRI), greyscale ultrasound (US), and mammography.(6) In some
studies, MRI has been shown to be superior to US.(7-8) however, MRI has the disadvantages
of being time-consuming, expensive, requiring intravenous contrast agent . Ultrasonic
elastography (UE) has been widely used to qualitatively and quantitatively evaluate
differences in lesion stiffness or elasticity. Currently, the two most frequently used UE
techniques for examination of breast diseases are strain elastography (SE) and shear-wave
elastography (SWE). In practice, UE is a complementary technique for differentiating
benign from malignant breast masses (9,10). Breast cancers with more aggressive
pathological properties tend to have higher stiffness values .Strain elastography (SE)
may be predictive of response in the early stage of treatment with high sensitivity (SEN)
and specificity (SPE).(11,12) Pretreatment tumor stiffness measured by shear wave
elastography (SWE) has a significant relationship with the subsequent reduction in tumor
cellularity.(13) In case of NACT, early evaluation of relative changes in tumor stiffness
could effectively predict the response and might indicate better therapeutic
strategies.(14)
Criteria for eligibility:
Study pop:
a total of 65 female patient with biopsy confirmation of invasive breast cancer
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Histologically confirmed invasive ductal carcinoma .
2. Age equal or above 18
Exclusion Criteria:
1. Previous radiation therapy or chemotherapy
2. Mass not detected by US
3. Non Mass lesion by MRI
4. Ductal carcinoma in situ
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
75 Years
Start date:
August 2023
Completion date:
April 2026
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05852743
